Sysmex America, Inc. · Class II · Cleared Aug 8, 2005
| K-number | K051199 |
| Device name | IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER |
| Applicant | Sysmex America, Inc. |
| Product code | GKZ |
| Device class | Class II |
| Decision date | Aug 8, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 864.5220 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov